Treatment of Claudication With a Peristaltic Pulse Pneumatic Device

Phase 2

• Conditions: Intermittent Claudication
• Interventions: Other: Exercise and lifestyle counseling; Device: Peristaltic pulse PCD

• Registration Number: NCT01007604
• Lead Sponsor: White River Junction Veterans Affairs Medical Center

Brief Summary

The purpose of this study is to evaluate the efficacy of a non-invasive peristaltic pulse pneumatic device (PCD) in the treatment of intermittent claudication in patients having documented peripheral arterial disease (PAD). The pneumatic device to be studied is FDA approved for the treatment of venous disease. While anecdotal evidence exists supporting a decrease in claudication symptoms, there are no previously published data on studies employing this compression device in the treatment of arterial disease. The investigators' primary hypothesis is that patients randomized to the intervention arm of the trial will experience an increase in mean walking ability as compared to the group receiving medical standard of care.

Detailed Description

Peripheral arterial disease (PAD) is a common disorder, affecting 12% of adults older than 50 years of age. Approximately one third of these patients experience intermittent claudication, defined as pain in the thigh or calf muscles during walking and that resolves with rest. Lower extremity pain is often severe enough to significantly limit ambulation, forcing many patients to seek medical care. Current treatments include two FDA-approved medications, supervised walking programs, arterial angioplasty and/or stent placement, and open arterial bypass surgery. The problem is that noninvasive treatments are oftentimes ineffective, while invasive treatments are effective but expensive.

A non-invasive lower extremity treatment that has shown success in treating lymphedema and venous insufficiency will be studied during this protocol to assess its effects on claudication symptoms. Half of the participants in this prospective, single-center randomized controlled trial will be treated with a pneumatic compression device in a home treatment program, while half will receive standard medical therapy. If effective, potential benefits are high, providing relief of personal disability and avoidance of costly surgical intervention.

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Last Update Submitted: 2009-11-03
• Study First Posted: 2009-11-04
• Last Update Posted: 2009-11-04
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Consistent claudication symptoms for at least 6 months
• ABIs at rest as follows: 0.5>ABI<0.8 minimally on one leg

Exclusion Criteria

• Refuses to consent
• Unlikely to be compliant with protocol
• Unable to perform treadmill test
• Current use of Cilostazol (Pletal) or Pentoxyphylline (Trental)
• Lower extremity surgery or endovascular procedure within the last 3 months
• Currently has a non-healing wound on either leg
• DVT in the past 3 months
• Unstable hypertension, angina, uncontrolled glucose levels
• Participating in a supervised exercise regimen
• Claudication medications regime changed within the last 3 months
• Diagnosis of Raynaud's Disease
• Requires a custom fabricated boot appliance
• Single limb amputees meeting inclusion criteria may participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise and lifestyle counselling	Exercise and lifestyle counseling	Patients will receive standard recommendations for ambulatory exercise and standard educational discussion of risk factor control, including smoking cessation.
PCD with peristaltic pulse waveform	Peristaltic pulse PCD	Daily use for two hours

Primary Outcome Measures

Name	Time	Method
Peak walking time (in seconds) during a graded-protocol treadmill test	initial; 3 months; 6 months

Secondary Outcome Measures

Name	Time	Method
Claudication onset time (in seconds) during a graded-protocol treadmill test	initial; 3 months; six months
Walking Impairment Questionnaire, including pain subscale, speed subscale and stair climbing subscale	initial; 3 months; 6 months
Ankle-Brachial Index (ABI)	initial; 3 months; 6 months
Integumentary changes as evaluated by photographs of lower extremity hair pattern and great toenail growth	initial; 3 months; 6 months

Trial Locations

Locations (1)

White River Junction VAMC; 🇺🇸 White River Junction, Vermont, United States